fromAdalimumab Level for IBD - The American Gastroenterological Association recommends optimal adalimumab trough concentration of 7.5 mcg/mL or greater in patients with active IBD. Data from separate clinical studies suggest an optimal adalimumab trough concentration greater than 4.5 mcg/mL or 8-12 mcg/mL. Sub-therapeutic adalimumab levels may be due to a patient not yet achieving a steady state trough level early in therapy, inadequate dosing, a dosing interval that is too long or accelerated adalimumab clearance. Accelerated adalimumab clearance may be explained by the presence of adalimumab anti-drug antibody or rheumatoid factor in the patient's serum, or may be caused by other diseases that indirectly lead to immunoglobulin loss (i.e. kidney disease, protein-losing gastroenteropathy). If the steady state trough adalimumab level is low despite adequate dosing, adalimumab anti-drug antibody testing should be considered.
Background: Adalimumab is an established treatment for Crohn's disease. Limited data are available regarding the relationship between adalimumab drug levels and serum/fecal markers of gut inflammation. We therefore aimed to characterize the relationship between adalimumab levels and biologic remission during maintenance therapy.
Methods: A single-center prospective cross-sectional study was undertaken on Crohn's disease patients who had received adalimumab therapy for a minimum of 12 weeks after induction. Data on clinical activity (Harvey-Bradshaw Index), C-reactive protein (CRP), adalimumab drug and antibody levels, and fecal calprotectin were collected. Biologic remission was defined as a CRP <5 mg/L and fecal calprotectin <250 µg/g. Adalimumab drug and antibody levels were processed using the Immundiagnostik monitor enzyme-linked immunosorbent assay.
Results: One hundred fifty-two patients had drug and antibody samples matched with CRP and fecal calprotectin. Patients in biologic remission had significantly higher adalimumab levels compared with others (12.0 µg/mL vs 8.0 µg/mL, P < 0.0001). Receiver operating characteristic curve analysis demonstrated an optimal adalimumab level of >8.5 µg/mL (sensitivity, 82.2%; specificity, 55.7%; likelihood ratio, 1.9) for predicting biologic remission. Multivariable logistic regression revealed that adalimumab levels >8.5 µg/mL were independently associated with biologic remission (odds ratio, 5.27; 95% confidence interval, 2.43-11.44; P < 0.0001).
Conclusions: Higher adalimumab levels are associated with biologic remission. An optimal level of >8.5 µg/mL was identified.
Thank you again for your response! This really makes a lot of sense.Generally to induce a remission the pediatric GI’s will go with prednisone over budesonide because it has a higher success rate.
As I mentioned in one of your other threads my older daughter had trouble getting Remicade to get hold of the disease even though she was at max dose and every 4 weeks. She did 6 weeks of EEN and since EEN brings down inflammation but also heals the mucosa, she got to a real good remission and the Remicade was able to hold it.
That level is low for Humira so moving to every week or even every 10 days might help. The addition of mtx could also help. But it also depends on what the antibodies are.
One other thing pediatric docs have found is that kids with active inflammation and their high metabolisms need a much higher trough level than adults. Inflammation alone sops up the drug and you actually end up pooping a lot of it out. So while a level of 5 is the published level for Remicade my daughters’ Docs shoot for a level greater than 10 when inflammation is present. Then when in remission you could start to cut back a little.
Good luck and Keep us posted
Uceris foam is not going to target the inflammation elsewhere - not in his small bowel or even higher up in his colon. It might help with the bleeding but only if the blood is coming from his rectum/sigmoid colon and it's topical, so it's not going to target inflammation in the deeper layers of his rectum. To be honest, I doubt it will help the Humira work better.Is it at all possible the Uceris foam could help enough to get the Humira to work better? If the bleeding, urgency, frequency don’t resolve by the time the 6 week course of Uceris Foam treatment is up, I wonder if she’ll add in an oral steroid…I may ask about Uceris oral. The waiting game is the worst.
Update/Question:Get a second opinion
None of the kiddie ibd drugs used ever follow fda dosing standards
Those fda standards are a better fit for adults
And kids never get the memo
You need a doc who is willing to fight to get your child into solid remission not state (“I don’t want to fight insurance imo
my kiddo was on humira before it was fda approved at all for pediatric crohns
Stelara is still not approved for pediatric crohns
And the dose he needs (as does most pediatric crohns patient per old Gi ) is much higher than fda approved adult dose of 90 mg every 8 weeks .
you need to find a second opinion quickly
Not sure how else to word it
Our current Gi went to battle with insurance for 8 months to get Stelara REAPPROVED - at every 4 weeks since Ds was doing so well on that dose
You need a doc who is willing to battle to get the meds needed